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PSMA-PET Scan for Prostate Cancer
Phase 2 & 3
Recruiting
Led By Kosj Yamoah, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
Age > 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will follow patients who had high-risk results on a previous study to see if they benefit from additional testing and treatment recommendations.
Who is the study for?
Men over 18 with high-risk prostate cancer, as indicated by a Decipher test score greater than 0.45, who were part of a previous study (MCC#18523) and have had either surgery or radiation therapy for their cancer. They must be in good physical condition (ECOG status 0-1) and have at least two years of follow-up data post-treatment.Check my eligibility
What is being tested?
The trial is testing PSMA-PET imaging using F-DCFPyL injection to detect early metastatic prostate cancer in men with high genomic classifier scores from an earlier study. The goal is to see how well this imaging technique works for those at higher risk.See study design
What are the potential side effects?
While the document does not specify side effects, generally PET scans are considered safe; however, there may be risks related to allergic reactions to the tracer substance or discomfort from lying still during the scan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My biopsy or surgical sample has undergone genomic testing.
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I am older than 18 years.
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My Decipher score is above 0.45, indicating high risk.
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I had surgery or radiation for prostate cancer over 2 years ago, with or without hormone therapy.
Select...
I was part of MCC#18523 and my Decipher score is above 0.45.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Secondary outcome measures
Rate of Positive PSMA-PET Findings
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radioactive Diagnostic ImagingExperimental Treatment2 Interventions
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.
Find a Location
Who is running the clinical trial?
Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,890 Total Patients Enrolled
17 Trials studying Prostate Cancer
2,274 Patients Enrolled for Prostate Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,432 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,124 Patients Enrolled for Prostate Cancer
Kosj Yamoah, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
284 Total Patients Enrolled
2 Trials studying Prostate Cancer
284 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My biopsy or surgical sample has undergone genomic testing.I haven't had certain types of scans or contrasts recently.I am older than 18 years.My Decipher score is above 0.45, indicating high risk.I had surgery or radiation for prostate cancer over 2 years ago, with or without hormone therapy.I was part of MCC#18523 and my Decipher score is above 0.45.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Radioactive Diagnostic Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the target condition able to enroll in this research project at this time?
"Yes, this trial is currently looking for enrolment. According to the listing on clinicaltrials.gov, the study was first posted on December 18th, 2019 and was last updated on August 18th, 2022."
Answered by AI
How many people are being given the chance to participate in this research?
"That is correct. As of August 18th, 2022, the study detailed on clinicaltrials.gov was still recruiting patients that it first posted about on December 18th, 2019. Currently, only 1 location is being used to screen the 60 participants needed for the trial."
Answered by AI
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